Analysis Of Baseline Predictors Of E Antigen Seroconversion In HBeAg-positive Chronic Hepatitis B Patients With Telbivudine Treatment

Objective:Investigate the efficacy of HBeAg seroconversion with telbivudine monotherapy in treatment-naive in chronic hepatitis B (CHB) patients. Observe the serological, biochemistry and virological response situations through different baseline age, sex, serum levels of HBsAg, HBeAg, ALT, HBVDNA in patients after treatment. To evaluate the correlation between baseline forecasting factor and HBeAg seroconversion, and provide the theory guidance to better and individualized use of telbivudine in treatment-naive in HBeAg-positive CHB patients.Methods:To analyze97cases of HBeAg-positive CHB patients received monotherapy of telbivudine in the department of infectious diseases from July2008to June2012. All the cases in accordance with the2005Chinese Clinical Practice Guidelines: management of chronic hepatitis B. Rounding out the top12months did not receive any other antiviral treatment, and eliminate the rest addicted to virus infection, and alcoholic liver or non alcoholic liver disease, drug hepatitis, autoimmune liver disease, etc. All patients were told to long-term, take medicine on time, and periodic review of possible virus resistance and adverse drug reactions, etc. Record its clinical data:age, gender, weight, blood tests and biochemical (bilirubin, albumin, ALT, creatinine, etc.), blood coagulation function, hepatitis B three-line, HBVDNA, AFP, color doppler ultrasound, etc. Give for telbivudine(Beijing Novartis)600mg once daily,48weeks of treatment, Observed the efficacy measures included the proportion of patients with normalization of ALT level [≤1.0×the upper level of normal (ULN)], undetectable serum HBV DNA (<lg3copies/mL), HBeAg loss, HBeAg seroconversion, HBsAg loss, HBsAg seroconversion at baseline and week12, week24, week48. Detection method:using Japan’s Hitachi automatic biochemical analyzer test biochemical indicators, Abbott Laboratories full automatic immune luminescence analyzer to detect HBV serum markers, immune fluorescence quantitative PCR method to detect the serum HBV DNA, the United States Amersham Biosciences fully automatic sequencing of PCR product direct sequencing machine to detect variable sites. Statistical processing:using SPSS16.0software for statistical analysis.Results:The normalization of ALT level at week12, week24, week48were62.9%,86.6%,92.8%of97patients respectively; undetectable rates of HBVDNA60.7%,78.7%,88.5%respectively. The rates of HBeAg loss at week12, week24, week48were17.5%,23.7%,32.0%and HBeAg seroconversion were12.7%,15.5%,30.9%in97HBeAg-positive patients respectively.4patients were observed drug--resistance in48weeks of treatment, the findings were rtM204I locus mutation. At48weeks occurred in25patients with elevated creatine kinase (CK), including1level18,2level 2,3level3and4level1person, no rhabdomyolysis and neuropathy clinical manifestations. The group under the age of40showed higher rates of HBeAg negative and HBeAg seroconversion, but no statistical significance (P>0.05). Baseline levels of HBsAg≤1500IU/mL group showed higher rates of HBeAg negative (42.3%vs20%; P＜0.05) and HBeAg seroconversion (42.3%vs17.8%; P＜0.05); baseline levels of ALT>5ULN group showed higher rates of HBeAg negative (45.1%vs17.4%; P＜0.01) and HBeAg seroconversion (45.1%vs15.2%; P＜0.01); baseline levels of HBsAg≤1500IU/mL and ALT>5ULN group showed higher rates of HBeAg negative (45%vs22.8%; P＜0.05) and HBeAg seroconversion (45%vs21.1%; P＜0.05); compare baseline levels of HBVDNA<8.0log10copies/mL group with HBVDNA≥8.0log10copies/mL group, have no statistical significance in HBeAg negative and seroconversion (P>0.05); compare baseline levels of HBeAg≤100S/CO group with HBeAg>100S/CO group, showed higher rates of HBeAg negative (P＜0.05), but no statistical significance in HBeAg seroconversion (P>0.05). To analyze whether baseline levels of gender, age, low level of HBsAg (≤1500IU/mL), high ALT levels (>5ULN), low HBVDNA load (<8.0logiocopies/mL) and low quantitative HBeAg (≤100S/CO) correlate with HBeAg seroconversion at week48or not. Univariate analysis revealed that low level of HBsAg (χ2=9.285, P-0.002), high ALT levels (χ2=10.108, P=0.001) were significantly associated with HBeAg seroconversion. Multiple regression analysis revealed high ALT level was a independent predictor for HBeAg seroconversion.Conclusions:1. CHB patients accepted LDT monotherapy in treatment-naive for48weeks had high rates of undetectable HBV DNA, normalization of ALT level, HBeAg loss and HBeAg seroconversion.2. CHB patients accepted LDT treatment with Low baseline HBsAg level (≤1500 IU/mL) and high baseline ALT level (>5ULN) presented satisfactory responses of HBeAg negative and HBeAg seroconversion at48week.3. Low baseline level HBsAg (≤1500IU/mL) and high baseline ALT levels (>5ULN) were significantly associated with HBeAg seroconversion at48week.4. High baseline ALT level (>5ULN) was a independent predictor for HBeAg seroconversion at48week.